Antisera, All Groups, Streptococcus Spp.

FDA product code GTZ · 105 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.3740
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-03 – 2001-11-30

GTZ 2001-11-30

BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

Applicant Binax, Inc.

K number K012521

View details →

GTZ 2001-11-08

UNI-GOLD STREP A TEST KIT

Applicant Trinity Biotech, Plc

K number K011709

View details →

GTZ 2001-03-15

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

Applicant Binax, Inc.

K number K010523

View details →

GTZ 1999-08-27

BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

Applicant Binax, Inc.

K number K991726

View details →

GTZ 1998-03-03

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II

Applicant Abbott Laboratories

K number K971522

View details →

GTZ 1997-07-23

STREP A OIA MAX

Applicant Biostar, Inc.

K number K962060

View details →

GTZ 1996-12-16

STREPTOLEX-STAT

Applicant Unipath , Ltd.

K number K962296

View details →

GTZ 1996-10-11

OSOM STREP A TEST

Applicant Wyntek Diagnostics, Inc.

K number K961423

View details →

GTZ 1996-10-07

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT

Applicant Excel Scientific, Inc.

K number K962146

View details →

GTZ 1996-04-15

CARDS Q.S. STREP A

Applicant Quidel Corp.

K number K955108

View details →

GTZ 1996-03-22

BINAX STREP A TEST

Applicant Binax, Inc.

K number K960712

View details →

GTZ 1996-01-26

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)

Applicant Abbott Laboratories

K number K952819

View details →

GTZ 1995-10-20

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)

Applicant Quidel Corp.

K number K954257

View details →

GTZ 1995-10-20

DIRECTIGEN 1-2-3 GROUP A STREP TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K951542

View details →

GTZ 1995-09-08

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)

Applicant Medix Biotech, Inc.

K number K952873

View details →

GTZ 1995-08-30

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY

Applicant Syntron Bioresearch, Inc.

K number K935554

View details →

GTZ 1995-08-30

QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU

Applicant Syntron Bioresearch, Inc.

K number K935475

View details →

GTZ 1995-08-14

ABBOTT TEST PACK STREP A TEST

Applicant Abbott Laboratories

K number K945571

View details →

GTZ 1995-01-27

PROLEX (STREPTOCCAL GROUPING LATEX KIT)

Applicant Pro-Lab, Inc.

K number K934383

View details →

GTZ 1994-11-28

REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST

Applicant Medical Diagnostic Technologies, Inc.

K number K942093

View details →

GTZ 1994-07-18

QUICKVUE IN-LINE ONE-STEP STREP A TEST

Applicant Quidel Corp.

K number K934484

View details →

GTZ 1994-07-18

MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010

Applicant Medix Biotech, Inc.

K number K932482

View details →

GTZ 1993-12-02

STREP A NEGATIVE CONTROL

Applicant Pacific Biotech, Inc.

K number K924461

View details →

GTZ 1993-04-06

QUIKPAC STREP A TEST

Applicant Syntron Bioresearch, Inc.

K number K924007

View details →

GTZ 1992-09-28

PRECISE STREP A

Applicant Becton Dickinson Advanced Diagnostics

K number K923673

View details →

GTZ 1992-07-16

TESTPACK PLUS STREP A

Applicant Abbott Laboratories

K number K922345

View details →

GTZ 1992-03-23

BBL STREP GROUPING KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K920565

View details →

GTZ 1992-01-30

STREP A OIA

Applicant Biosearch Medical Products, Inc.

K number K915758

View details →

GTZ 1991-10-31

OIA STREP A

Applicant Biosearch Medical Products, Inc.

K number K912889

View details →

GTZ 1991-08-07

GROUP A STREP POSITIVE AND NEGATIVE CONTROLS

Applicant Quidel Corp.

K number K912868

View details →

GTZ 1991-07-24

ICON STREP B IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K911417

View details →

GTZ 1991-03-29

STREPTEX ACID EXTRACTION KIT

Applicant Wellcome Diagnostics

K number K910797

View details →

GTZ 1990-08-22

REDITEST STREP A TEST KIT

Applicant Boehringer Mannheim Corp.

K number K903194

View details →

GTZ 1990-05-21

PATHO DX STREP D

Applicant Diagnostic Products Corp.

K number K902038

View details →

GTZ 1990-05-11

TESTPACK PLUS STREP A

Applicant Abbott Laboratories

K number K901274

View details →

GTZ 1990-02-16

QUIDEL GROUP B STREP TEST

Applicant Quidel Corp.

K number K896265

View details →

GTZ 1990-01-22

VENTRESIGN STREP A TEST

Applicant Ventrex Laboratories, Inc.

K number K897083

View details →

GTZ 1989-12-13

CARDS O.S.(TM) STREP A

Applicant Pacific Biotech, Inc.

K number K896221

View details →

GTZ 1989-11-29

IMMUNOCARD STREP A TEST

Applicant Disease Detection International, Inc.

K number K896109

View details →

GTZ 1989-11-29

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION

Applicant Gen-Probe, Inc.

K number K895103

View details →

GTZ 1989-11-14

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.

Applicant Gen-Probe, Inc.

K number K894711

View details →

GTZ 1989-08-15

LEECO VIS-DISK STREP-A (EIA)

Applicant Leeco Diagnostics, Inc.

K number K894122

View details →

GTZ 1989-06-23

CLEARVIEW STREP A

Applicant Unipath , Ltd.

K number K893422

View details →

GTZ 1989-03-27

VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT

Applicant Adi Diagnostics, Inc.

K number K890840

View details →

GTZ 1989-02-07

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST

Applicant Armkel, LLC

K number K885003

View details →

GTZ 1988-12-22

GROUP A STREP, BETA-STREP

Applicant Ampcor, Inc.

K number K884750

View details →

GTZ 1988-10-12

QUIDEL GROUP A STREP TEST

Applicant Quidel Corp.

K number K883999

View details →

GTZ 1988-04-21

KODAK SURECELL STREP A TEST KIT

Applicant Eastman Kodak Company

K number K881457

View details →

GTZ 1988-04-12

V-TREND STREP A TEST

Applicant Texas Immunology, Inc.

K number K880483

View details →

GTZ 1988-03-03

TARGET STREP A

Applicant V-Tech, Inc.

K number K880460

View details →

GTZ 1988-03-01

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT

Applicant Allelix Diagnostics, Inc.

K number K880665

View details →

GTZ 1988-02-19

RAPID COLORIMETRIC DIRECT STREP A TEST

Applicant New Horizons Diagnostics Co.

K number K874761

View details →

GTZ 1987-11-20

BINAX EQUATE STREP B

Applicant Binax, Inc.

K number K872904

View details →

GTZ 1987-11-12

NOVA STREP A

Applicant Synbiotics Corp.

K number K873784

View details →

GTZ 1987-09-30

SURE-STREP A TEST KIT CATALOG NO. MB-1083

Applicant Medix Biotech, Inc.

K number K872346

View details →

GTZ 1987-09-29

QTEST STREP

Applicant Quidel Corp.

K number K872961

View details →

GTZ 1987-08-27

BACTIGEN GROUP B STREPTOCOCCUS-CS TEST

Applicant Armkel, LLC

K number K872114

View details →

GTZ 1987-08-24

DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K872493

View details →

GTZ 1987-06-17

PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT

Applicant Diagnostic Products Corp.

K number K871831

View details →

GTZ 1987-06-17

ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT

Applicant Allelix, Inc.

K number K871620

View details →

GTZ 1987-04-28

BACTO(R) STREP GROUP KIT

Applicant Difco Laboratories, Inc.

K number K870854

View details →

GTZ 1987-03-10

DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K870155

View details →

GTZ 1987-02-03

LEECO VIS-CUBE STREP A (EIA)

Applicant Leeco Diagnostics, Inc.

K number K864170

View details →

GTZ 1987-01-13

REVEAL COLOUR STREP A ZL16

Applicant Wellcome Diagnostics

K number K864206

View details →

GTZ 1986-12-22

BINAX STREP A

Applicant Binax, Inc.

K number K863908

View details →

GTZ 1986-11-26

CARDS(TM) STREP A CATALOG NO. CR-7545

Applicant Pacific Biotech, Inc.

K number K863647

View details →

GTZ 1986-08-12

SEROIDEN STREPTO KIT 'EIKEN'

Applicant Syn-Kit, Inc.

K number K861098

View details →

GTZ 1986-05-16

EZ DETECT, 5 MINUTE STREP-A COLOR TEST

Applicant Self Care Systems, Inc.

K number K860923

View details →

GTZ 1986-05-13

LEECO-SCREEN, STREP A (EIA)

Applicant Leeco Diagnostics, Inc.

K number K860947

View details →

GTZ 1986-05-13

DIRECTIGEN COMBO MENINGITIS TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K860768

View details →

GTZ 1986-04-04

TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K860778

View details →

GTZ 1986-04-04

MUREX SUDS GROUP A STREP

Applicant Murex Corp.

K number K860576

View details →

GTZ 1986-03-18

DIFCO STREP A LATEX TEST

Applicant Difco Laboratories, Inc.

K number K854978

View details →

GTZ 1986-03-11

OXOID STREPTOCOCAL GROUPING KIT

Applicant Oxoid U.S.A., Inc.

K number K854929

View details →

GTZ 1986-03-04

INSTA KIT FOR GROUP A STREP ID

Applicant Mead Johnson & Co.

K number K860247

View details →

GTZ 1986-01-03

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

Applicant American Micro Scan

K number K854447

View details →

GTZ 1985-12-05

ABBOTT STREP A P.S.D.

Applicant Abbott Laboratories

K number K852266

View details →

GTZ 1985-10-23

PHADIRECT STREP A TEST

Applicant Pharmacia, Inc.

K number K854150

View details →

GTZ 1985-08-01

CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.

Applicant Marion Laboratories, Inc.

K number K853073

View details →

GTZ 1985-07-30

QUIDEL QUEST STREP GROUP A TEST

Applicant Quidel Corp.

K number K852806

View details →

GTZ 1985-07-24

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST

Applicant Smithkline Diagnostics, Inc.

K number K852841

View details →

GTZ 1985-07-05

LATEX AGGLUTINATION TEST

Applicant New Horizons Diagnostics Co.

K number K851132

View details →

GTZ 1985-05-29

BACTIGEN GROUP B STREPTOCOCCUS TEST

Applicant Armkel, LLC

K number K850772

View details →

GTZ 1985-05-02

PATHO DX LATEX AGGLUTINATION STREP B KIT

Applicant Diagnostic Products Corp.

K number K845022

View details →

GTZ 1985-04-08

STREP A QUICK

Applicant Abbott Laboratories

K number K850831

View details →

GTZ 1985-04-08

CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES

Applicant Abbott Laboratories

K number K850256

View details →

GTZ 1985-01-16

VENTRESCREEN STREP A TEST

Applicant Ventrex Laboratories, Inc.

K number K844855

View details →

GTZ 1985-01-08

RESPIRALEX LATEX AGGLUTINATION TEST

Applicant Orion Diagnostica, Inc.

K number K844399

View details →

GTZ 1985-01-04

DIRECTIGEN GROUP A STREP TEST KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K843713

View details →

GTZ 1984-11-27

PHARMACIA STREP A DIRECT SWAB TEST

Applicant Pharmacia, Inc.

K number K844107

View details →

GTZ 1984-10-30

DETECT-A-STREP

Applicant Antibodies, Inc.

K number K843590

View details →

GTZ 1984-08-16

STREPTEX DIRECT A ZL14

Applicant Wellcome Diagnostics

K number K842827

View details →

GTZ 1984-07-02

PATHO DX LATEX AGGLUTINATION STREP A

Applicant Diagnostic Products Corp.

K number K842383

View details →

GTZ 1984-04-04

DETECT GROUP A STREP TEST

Applicant Difco Laboratories, Inc.

K number K834582

View details →

GTZ 1983-09-26

DIRECTIGEN GROUP B STREP TEST KIT-SERUM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K831991

View details →

GTZ 1983-04-27

PHADEBACT STREP F TEST

Applicant Pharmacia, Inc.

K number K830445

View details →

GTZ 1983-03-01

ABBOTT LABORATORIES STREP A EIA

Applicant Abbott Laboratories

K number K823569

View details →

GTZ 1982-05-13

MERITECASTREP (TM)

Applicant Meridian Diagnostics, Inc.

K number K821100

View details →

GTZ 1982-02-18

WELLCOGEN GROUP B

Applicant Burroughs Wellcome Co.

K number K820069

View details →

GTZ 1980-10-10

SERO STREP KIT

Applicant Sacks Farms Biological Products

K number K801775

View details →